The following data is part of a premarket notification filed by Global Instrumentation Llc with the FDA for M5 Recorder.
| Device ID | K202456 |
| 510k Number | K202456 |
| Device Name: | M5 Recorder |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Global Instrumentation LLC 8104 Cazenovia Road Manlius, NY 13104 |
| Contact | Jason Demaso |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2020-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815187020600 | K202456 | 000 |
| 00815187020440 | K202456 | 000 |
| 00815187020457 | K202456 | 000 |
| 00815187020587 | K202456 | 000 |
| 00815187020594 | K202456 | 000 |
| 00815187020570 | K202456 | 000 |
| 00815187020433 | K202456 | 000 |
| 00815187020471 | K202456 | 000 |
| 00815187020549 | K202456 | 000 |
| 00815187020556 | K202456 | 000 |
| 00815187020563 | K202456 | 000 |
| 00815187020112 | K202456 | 000 |